METUCHEN, NJ, USA I May 11, 2021 I Tevogen Bio, a clinical stage biotechnology company, announced that its investigational COVID-19 therapy, TVGN-489, demonstrated strong antiviral activity against SARS-CoV-2 in the preclinical study. The promising preclinical data was presented yesterday by preeminent expert in allogeneic stem cell and T cell therapy, Dr. Neal Flomenberg, Deputy Director of the Sidney Kimmel Cancer Center – Jefferson Health and Professor and Chairman of the Department of Medical Oncology at Thomas Jefferson University at the 104th Annual Meeting of the American Association of Immunologists.

TVGN-489 is a highly enriched product of cytotoxic T cells (CTLs) trained to recognize peptides encoded by SARS-CoV-2 and eliminate viral infected cells. Tevogen’s proprietary technology resulted in at least a 600-fold expansion and enrichment of the COVID-19 reactive cells found in the blood of individuals who had recovered from a COVID-19 infection without any evidence that these cells were demonstrating phenotypic or functional evidence of exhaustion. COVID-19 reactive cells comprised 70% or more of the cells in initial batches of this product. In 4-hour assays, these cells were able to destroy 75-80% of SARS-CoV-2 infected cells at a very low E:T ratio of 3:1, proving much stronger cytolytic activity than previously reported in similar allogeneic cytotoxic T cell therapeutic approaches to treat viral infections. These data suggest the viability of TVGN-489 as a potentially curative treatment for COVID-19. The goal of this investigational product is to provide off-the-shelf, preformed CTLs, initially to high-risk individuals, whose immune system may be slow at mounting their own immune response to the virus or whose response may be compromised due to various underlying conditions.

“What is most encouraging is that Tevogen’s TVGN-489 CTLs have reached levels of purity and effectiveness in killing COVID-19 infected cells not seen in any previously reported literature,” said Ryan Saadi, MD, MPH, Chairman and CEO of Tevogen Bio. “The breakthrough nature of Tevogen’s technology is that we can overcome two main barriers to develop accessible off-the-shelf T cell therapy for large patient populations: purity and quantity. Sufficient cells have already been prepared to support our initial clinical trial which will be conducted at Thomas Jefferson University.”

About These Data:

“TVGN-489 is quite unique in that it is not a “one size fits all” treatment,” said Dr. Neal Flomenberg. He added, “A patient and donor must match for certain cell surface markers known as HLA for the CTLs to be effective and so, to treat the population, a panel of CTLs must be developed. One may consider this as a personalized therapy for the masses. Very important to note is that T cell targets are spread throughout many of the virus’s proteins which makes T-cell therapy much, much less likely to be rendered inactive due to mutation.” Dr. Flomenberg also noted, “While vaccines are critical to prevent COVID-19 infections, treatment strategies are also essential in addition to these preventative approaches. The issues of viral mutation, vaccine distribution and acceptance, as well as uncertainty about the duration of immunity collectively suggest that we need to be focused on treatment as well as prevention.”

TVGN-489 T cell therapy for COVID-19 involves harvesting T lymphocytes from healthy donors who have recovered from COVID-19. A limited number of carefully selected peptides from the entire viral genome are used to serially activate and expand the CD8+ subset which contains the CTLs. The cells undergo an enrichment step which also helps increase their purity. The first efforts focused on HLA-A*02:01, the most common HLA allele in the population overall. Tevogen Bio is investigating similar approaches to generate CTLs to treat other viral diseases, and a platform technology for new viruses which may arise in the future. Tevogen’s research pipeline also includes targeted CTL therapeutics for both virally and non-virally induced cancers using a variety of proprietary approaches.

About Tevogen Bio

Tevogen Bio was formed after decades of research by its contributors to concentrate and leverage their expertise, spanning multiple sectors of the healthcare industry, to help address some of the most common and deadly illnesses known today. The company’s mission is to provide equitable access to curative and preventative advanced life saving medical innovations, to positively impact global public health.

About Dr. Neal Flomenberg

Dr. Neal Flomenberg is the Chairman of the Department of Medical Oncology and Deputy Director of the Sidney Kimmel Cancer Center at Jefferson University in Philadelphia. Dr. Flomenberg launched Jefferson’s Blood and Marrow Transplantation (BMT) Program in 1995. Throughout his four decades of practice, he has maintained a longstanding interest in the immunogenetics and immunology of stem cell transplantation, with the goal of making transplantation safer and more widely available. He is board certified in the fields of internal medicine, hematology, and medical oncology.

SOURCE: Tevogen Bio